BILL ANALYSIS �
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|Hearing Date:June 17, 2013 |Bill No:AB |
| |1215 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Ted W. Lieu, Chair
Bill No: AB 1215Author:Hagman and Holden
As Amended: April 9, 2013 Fiscal: No
SUBJECT: Clinical laboratories.
SUMMARY: Expands the definition of "laboratory director" to include a
duly licensed clinical laboratory scientist and a duly licensed
limited clinical laboratory scientist and authorizes these individuals
to perform the duties and responsibilities of a waived laboratory
director, as specified, under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA).
Existing State Law:
1) Provides for the licensure and regulation of clinical laboratories
and their personnel by the California Department of Public Health
and requires clinical laboratories to be operated under the
supervision of a laboratory director. (Business and Professions
Code (BPC) � 1260 et seq.; California Code of Regulations, Title
17, Division 1, Chapter 2)
2) Prohibits the performance of a clinical laboratory test or
examination classified as waived under the federal CLIA unless the
test or examination is performed under the overall operation and
administration of a laboratory director and is performed by
specified persons, including certain health care personnel. (BPC �
1209)
3) Defines "clinical laboratory scientist" (CLS) as any person other
than a licensed clinical laboratory bioanalyst or trainee who is
licensed to engage in clinical laboratory practice under the
supervision of a laboratory director. (BPC � 1204)
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4) Specifies that a licensed CLS may perform clinical laboratory
tests or examinations classified as of high complexity under CLIA
and the duties and responsibilities of a technical consultant,
clinical consultant, technical supervisor and general supervisor,
as specified under CLIA, in the specialties of histocompatibility,
microbiology, diagnostic immunology, chemistry, hematology,
immunohematology, genetics, or other specialty or subspecialty
specified by regulation adopted by the department. A licensed CLS
may perform any clinical laboratory test or examination classified
as waived or of moderate complexity under CLIA.
(BPC � 1204)
5) Defines a "laboratory director" as any person who is a duly
licensed physician and surgeon, or, only for purposes of a clinical
laboratory test or examination classified as waived, is a duly
licensed naturopathic doctor, or is licensed to direct a clinical
laboratory and who substantially meets the laboratory director
qualifications under CLIA for the type and complexity of tests
being offered by the laboratory. (BPC � 1209)
Existing Federal Law:
1) Establishes CLIA under federal law, which regulates clinical
laboratories that perform tests on human specimens and sets
standards for facility administration, personnel qualifications and
quality control. These standards apply to all settings, including
commercial, hospital or physician office laboratories. (Code of
Federal Regulations (CFR) Title 42 � 493)
2) Defines CLIA waived tests as simple laboratory examinations and
procedures that are approved by the Food and Drug Administration
(FDA) for home use, employ methodologies that are simple and
accurate as to render the likelihood of erroneous results
negligible or pose no reasonable risk of harm to the patient if the
test is performed incorrectly.
(CFR Title 42 � 493)
This bill:
1) Expands the definition of "laboratory director" for purposes of a
clinical laboratory test or examination classified as waived to
include a duly licensed CLS and a duly licensed limited clinical
laboratory scientist (LCLS).
2) Indicates that a person licensed as a CLS and LCLS qualified under
CLIA may perform tests and the duties and responsibilities of a
waived laboratory director as specified under CLIA.
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FISCAL EFFECT: This bill has been keyed "non-fiscal" by Legislative
Counsel.
COMMENTS:
1. Purpose. This bill is sponsored jointly by the United Nurses
Associations of California/ Union of Health Care Professionals,
Western States Council of the United Food & Commercial Workers ,
Engineers and Scientists of California and the California
Association for Medical Laboratory Technology . According to the
Author, "The implementation of the Affordable Care Act will extend
health benefits to an estimated 7 million uninsured Californians by
2018. The newly insured will increase the demand for care and
auxiliary services such as clinical laboratory testing. Therefore,
access to clinical laboratory tests must be improved without
compromising testing accuracy and quality or patient safety. Under
California law, the very practitioners specifically trained and
licensed in clinical laboratory science cannot be directors of
laboratories conducting "waived" tests?Currently, there is a
shortage of clinical laboratory personnel. If more waived tests
could be performed by non laboratory personnel at the point of
contact with their healthcare providers, this would reduce the
demand for waived testing at high complexity laboratories."
2. Background. Federal Clinical Laboratory Improvement Amendments of
1988 (CLIA) .
CLIA law specified that laboratory requirements be based on the
complexity of the test performed. It also established provisions
for categorizing a test as waived. Tests may be waived from
regulatory oversight if they meet certain requirements established
by the statute. On February 28, 1992, regulations were published
to implement CLIA.
Federal Definition of CLIA Waived Tests . According to Federal
Regulation 493.15, CLIA-waived tests are test systems that are
simple laboratory examinations and procedures which are cleared by
FDA for home use, employ methodologies that are so simple and
accurate as to render the likelihood of erroneous results
negligible, or pose no reasonable risk of harm to the patient if
the test is performed incorrectly.
Federal Oversight of the CLIA Program . Center for Medicare and
Medicaid Services (CMS) regulates all laboratory testing (except
research) performed on humans in the U.S. through the CLIA. In
total, CLIA covers approximately 175,000 laboratory entities. The
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Division of Laboratory Services, within the Survey and
Certification Group, under the CMS has the responsibility for
implementing the CLIA Program.
Federal Certificate of Waiver . Under federal CLIA law, a
"Certificate of Waiver" is defined as a certificate issued or
reissued to a laboratory. The primary obligation of the holder of
a Certificate of Waiver is to ensure that the manufacturer's
directions for giving the test are followed. (CFR Title 42 �
493.2(5))
A laboratory may qualify for a Certificate of Waiver if it
restricts the tests that it performs to certain tests or
examinations such as dipstick tests, ovulation tests, urine
pregnancy tests and blood glucose monitoring by FDA devices
approved for home use (Public Health Service Act � 353).
Additionally qualifications include: (CFR Title 42 � 493.17
1(i)(A)(B))
a) Minimal scientific and technical knowledge is required to
perform the tests.
b) The knowledge required to perform the tests may be obtained
through on-the-job instruction.
c) The individual who administers the test must follow the
manufacturer's instructions.
California Clinical Laboratory Personnel Requirements . All persons
performing, supervising, consulting on, or directing clinical
laboratory tests or examinations in California must meet the
requirements outlined in the Business and Professions Code
irrespective of whether the clinical laboratory is operated under a
CLIA certificate or under a state license or registration. (CCR
Title 17 � 1039.2 (a))
California Oversight of the CLIA Program . The California
Laboratory Field Services (LFS) ensures compliance with state and
federal clinical laboratory laws and regulations by performing
bi-annual onsite inspections of laboratories to ensure accuracy and
reliability of laboratory test results. LFS performs routine
inspections of over 800 laboratories each year. The program is
also responsible for inspection of over 200 laboratories with a
CLIA Certificate of Waiver.
1. Both CLSs and LCLSs as Laboratory Directors. Both CLSs and LCLS
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are regulated by the California Department of Public Health. A
LCLS is an individual who is duly licensed as a clinical chemist,
clinical microbiologist or clinical toxicologist scientist. Both
CLSs and LCLSs may perform clinical laboratory tests or
examinations classified as waived, moderate or high complexity
under CLIA. These tests generally fall within the specialty areas
of histocompatibility, microbiology, diagnostic immunology,
chemistry, hematology, immunohematology, genetics or other
specialty as specified in statute. Currently, a CLS or LCLS is
able to engage in clinical laboratory practice under the overall
operation and
administration of a laboratory director. This measure will allow a
CLS or LCLS to serve as a director of a waived laboratory.
2. Arguments in Support. The United Nurses Associations of
California/ Union of Health Care Professionals (Sponsor) and the
American Federation of State, County and Municipal Employees
supports the bill. Both organizations state the following in
their support letters, "CLSs perform waived, moderate and high
complexity laboratory testing, including analyzing body fluids,
cells and tissue samples. CLSs maintain instruments to assure the
highest level of accuracy. They supervise unlicensed staff?No
other healthcare professionals possess these unique qualifications.
This is far more education and training in clinical laboratory
practice than anyone currently allowed to direct a waived
laboratory except a pathologist? AB 1215 will ultimately help
alleviate shortages of clinical laboratory personnel, thus
resulting in greater access to safe, simple and economical tests
that will play a crucial role in meeting future demands for
clinical laboratory testing."
The Western States Council of the United Food & Commercial Workers
and the Engineers and Scientists of California- Local 20 of the
International Federation of Professional and Technical Engineers
(Sponsors) wrote a joint letter of support. In it they state,
"Given that it is the CLS, unlike the other professions?who is
specifically educated, trained and licensed in the field of
clinical laboratory science it makes sense to extend this statutory
authorization to them as well. This is especially true as we begin
to implement the Affordable Care Act, extending access to
healthcare to millions more Californians."
The California Association for Medical Laboratory Technology
(Sponsor) similarly supports the bill. In their letter they note,
"With the implementation of the Affordable Care Act, which will
extend health benefits to some 4.7 million Californians, there will
be greater demand for care and ancillary services such as clinical
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laboratory testing. Hence, access to clinical laboratory tests
must be improved without compromising testing accuracy and quality
or patient safety."
The California Society of Pathologists indicates, "With the
upcoming implementation of the ACA there will be and influx of new
patients who will need to access clinical lab testing for
diagnostic purposes. The use of CLSs in this capacity will improve
availability and access to these services."
A support letter was also received from the Blood Centers of
California who remark, "Only Clinical Laboratory Scientists once
licensed are allowed to perform the highly complex and
sophisticated tests performed in our laboratories. We currently
have a shortage of licensed health care personnel and with the full
implementation of health care reform, we can anticipate an increase
of patients and their need for laboratory tests as well. To expand
the definition of 'laboratory director' will increase access to
clinical tests including waived tests."
3. Current Related Legislation. AB 399 (Fox) of 2013, would authorize
the DPH to establish application and license renewal fees for new
license categories that exceed the costs for implementation.
( Status : This bill is pending in the Assembly Business,
Professions and Consumer Protection Committee.)
AB 830 (Holden) of 2013, would require DPH to promulgate
regulations by January 1, 2015, requiring any facility operating a
clinical laboratory to provide specified training to CLSs, medical
laboratory technicians, and any individuals who are charged with
direct and responsible supervision of either a CLS or a medical
laboratory technician. ( Status : This bill is pending in Assembly
Business, Professions and Consumer Protection Committee.)
4. Previous Related Legislation. AB 761 (Hern�ndez, Chapter 714,
Statutes of 2012) allowed optometrists to independently perform
waived clinical laboratory tests necessary for the diagnosis of
conditions and diseases of the eye.
SB 1481 (Negrete McLeod, Chapter 874, Statutes of 2012) eliminated
the requirement that only allowed a laboratory director to perform
CLIA waived tests and permitted pharmacists to administer certain
tests that were approved by the federal Food and Drug
Administration for sale to the public without a prescription in the
form of an over-the-counter test kit upon customer request,
provided that the pharmacy obtained a CLIA certificate of waiver
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and a registration from the State Department of Public Health and
comply with all other requirements governing clinical laboratories,
as specified.
SB 1246 (Negrete McLeod, Chapter 523, Statutes of 2010) included
naturopathic doctors in the list of health care practitioners who
can perform a clinical laboratory test or examination classified as
waived under CLIA and designated naturopathic doctors as clinical
laboratory directors for CLIA-waived tests only.
AB 1442 (Feuer of 2007) would have required clinical laboratories
that perform tests to screen for human immunodeficiency virus that
are classified as waived under CLIA to enroll in a proficiency
testing program and to obtain the appropriate license or
registration from DPH, as specified. ( Status : This bill failed
passage on the Assembly Floor.)
AB 185 (Dymally of 2007) would have expanded the duties that
unlicensed personnel are authorized to perform in a clinical
laboratory and would have revised the level of supervision required
when unlicensed personnel perform them. ( Status : AB 185 failed
passage in Assembly Business and Professions Committee.)
AB 1370 (Matthews of 2005) would have included a pharmacist within
the definition of laboratory director if the clinical laboratory
test or examination is a routine patient assessment procedure, as
defined. ( Status : AB 1370 failed passage in Assembly Business and
Professions Committee.)
AB 433 (Nava of 2005) would have exempted physician office
laboratories from licensure and regulatory requirements governing
clinical laboratories and their personnel by the Department of
Health Services. ( Status : AB 433 failed passage in Assembly
Health Committee.)
NOTE : Double-referral to Senate Health Committee second.
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SUPPORT AND OPPOSITION:
Support:
California Association For Medical Laboratory Technology (Sponsor)
Engineers and Scientists of California- Local 20 of the International
Federation of Professional and Technical Engineers (Sponsor)
United Nurses Associations of California/ Union of Health Care
Professionals (Sponsor)
Western States Council of the United Food & Commercial Workers
(Sponsor)
American Federation of State, County and Municipal Employees
Blood Centers of California
California Society of Pathologists
Opposition:
None on file as of June 11, 2013
Consultant:Le Ondra Clark, Ph.D.